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RSS FeedPosted by Michael Wonder on 21 May 2025
Lilly's Kisunla (donanemab) receives marketing authorisation in Australia for the treatment of early symptomatic Alzheimer's disease
21 May 2025 - The authorisation in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers. ...
Posted by Michael Wonder on 21 May 2025
US FDA grants approval for Jivi anti-hemophilic factor (recombinant), PEGylated-aucl in paediatric patients 7 to under 12 years of age with haemophilia A
19 May 2025 - Bayer announced that the US FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII ...
Posted by Michael Wonder on 20 May 2025
US FDA approves BLA for Novavax's COVID-19 vaccine
19 May 2025 - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the US. ...
Posted by Michael Wonder on 18 May 2025
FDA clears first blood test used in diagnosing Alzheimer’s disease
16 May 2025 - New test provides less invasive option, reduces reliance on PET scans and increases diagnosis accessibility. ...
Posted by Michael Wonder on 18 May 2025
MHRA approves guselkumab for Crohn’s disease and ulcerative colitis
16 May 2025 - The MHRA has today approved guselkumab (Tremfya) to treat Crohn’s disease and ulcerative colitis. ...
Posted by Michael Wonder on 17 May 2025
MHRA approves vaccine to protect against pneumococcal infections such as pneumonia and meningitis
15 May 2025 - The MHRA has today approved a vaccine (Capvaxive) for people aged 18 years and older to help ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 16 May 2025
Amneal receives US FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults
15 May 2025 - Product will be available for appropriate patients in the second half of 2025 ...
Posted by Michael Wonder on 16 May 2025
ICER publishes final evidence report on treatment for retinitis pigmentosa
15 May 2025 - Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of ...
Posted by Michael Wonder on 16 May 2025
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...
Posted by Michael Wonder on 15 May 2025
Deal agreed for continued access to life-changing treatment for rare inherited disease
14 May 2025 - NICE is consulting on draft guidance for cerliponase alfa for treating neuronal ceroid lipofuscinosis type 2, ...
Posted by Michael Wonder on 14 May 2025
FDA grants accelerated approval to telisotuzumab vedotin-tllv for non-small cell lung cancer with high c-Met protein overexpression
14 May 2025 - Today, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met-directed antibody and microtubule ...
Posted by Michael Wonder on 14 May 2025
FDA approves belzutifan for pheochromocytoma or paraganglioma
14 May 2025 - Today, the FDA approved belzutifan (Welireg, Merck) for adult and paediatric patients 12 years and older ...
Posted by Michael Wonder on 14 May 2025
MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura
12 May 2025 - The MHRA has today approved rADAMTS13 (Adzynma), the first UK treatment to treat congenital thrombotic thrombocytopenic purpura ...
Posted by Michael Wonder on 13 May 2025
SMC - May 2025 decisions
13 May 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...